A Randomized, Controlled, Multi-center Clinical Study on the Efficacy of Single-port Inflatable Mediastinoscopy Combined With Laparoscopic-assisted Small Incision Surgery and Thoracoscopy Combined With Laparoscopic Surgery for Radical Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,164
- 试验地点
- 1
- 主要终点
- Perioperative incidence of cardiopulmonary complications
研究概览
简要总结
We previously developed a novel non-trans thoracic esophagectomy, the single-port inflatable mediastinoscopy combined with laparoscopy for the radical esophagectomy of esophageal cancer.This study is evaluating the feasibility and safety of radical resection of single-port inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-port inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.
详细描述
To reduce postoperative pulmonary complications, considerable efforts have been made to develop the nontransthoracic esophagectomy for esophageal cancer. For instance, esophageal stripping and transhiatal esophagectomy are the nontransthoracic operations developed for treatment for esophageal cancer. These methods possess several advantages, including non-thoracotomy, less postoperative pain, less postoperative cardiac and pulmonary complications, and safer for elderly patients. However, these two methods are limited with the poor surgical view, poor mediastinal lymph node dissection (especially upper mediastinal lymph nodes), and high risk of bleeding.
In 2015 and 2016, Prof. Fujiwara has developed novel surgical methods on the dissection of upper mediastinal lymph nodes using single-port mediastinoscopy through the cervical incision and the lower mediastinal lymph nodes (including the subcarinal lymph nodes) by laparoscopy, respectively.For the first time, non-transthoracic radical resection of esophageal cancer could be achieved along with the dissection of all the mediastinal lymph nodes. Based on the Fujiwara's method, we further improved this surgical method to the"single-port inflatable mediastinoscopy combined with laparoscopy for the radical treatment of esophageal cancer"and has successfully performed this novel surgical method for the first case in March 2016. We have completed over 200 cases of radical resection of esophageal carcinoma using this novel surgical technique from May 2016 to August 2021.
This is a prospective, multicenter, open clinical study in which 1164 patients (including 10% drop-off rate) who require surgical treatment are scheduled to be included in the study. Prior to any screening process, each subject / legal guardian should sign the informed consent form. Screening tests are used to determine whether each subject is eligible for the study. Eligible subjects who meet the standard will be treated with radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma and followed up until 5 years postoperatively. Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ age ≤ 75 years old, no gender limit;
- •Patients who are diagnosed as esophageal malignant tumor by cytology or histology, and agree to undergo surgical treatment;
- •The preoperative clinical tumor staging is T1-2N0-1M0 patients; or T3N1-2M0 patients undergo neoadjuvant treatment (neoadjuvant chemotherapy, neoadjuvant chemoradiation, neoadjuvant radiotherapy, neoadjuvant chemotherapy and immunotherapy, neoadjuvant radiotherapy and immunotherapy After treatment), assess the tumor to achieve partial response (PR) and surgical resection is feasible;
- •The tumor is located in the thoracic esophagus;
- •The tumor has not invaded the surrounding vital organs and has metastasized far away;
- •The function of major organs is basically normal: general anesthesia is acceptable for lung function; NYHA grade of heart function is 0~1;
- •Voluntarily sign an informed consent form before the study. The patient and/or his legal representative have the ability to fully understand the content, process and possible adverse reactions of the experiment, and enable the patient to comply with the visits stipulated in the plan;
排除标准
- •People who suffer from other malignant tumors at the same time;
- •Patients with a history of esophagus or gastrectomy;
- •Patients with a history of mediastinal surgery or extensive abdominal cavity adhesion;
- •Patients with basic diseases such as cardiovascular and cerebrovascular diseases;
- •People suffering from mental, mental or neurological diseases;
- •Patients with cachexia and severe malnutrition who cannot tolerate surgery;
- •Recent recurrence of gastric ulcer, history of gastric bleeding and other serious underlying diseases;
- •Patients with surgical contraindications such as blood coagulation dysfunction, HIV antibody positive, and poorly controlled clinically severe infections;
- •Patients with other comorbid diseases (such as liver and kidney function abnormalities, etc.) or concomitant medications, which may have an impact on the results of this study based on the judgment of the investigator.
- •Patients who have participated in other clinical studies;
- •Others judged by the investigator to be unsuitable to participate in this clinical trial.
结局指标
主要结局
Perioperative incidence of cardiopulmonary complications
时间窗: Through operation completion, an average of 12 days
Perioperative complications include: pulmonary infection, respiratory failure, managed pleural effusion, heart failure, myocardial infarction, managed arrhythmia, anastomotic fistula or gastric fistula, recurrent laryngeal nerve injury, chylothorax, unscheduled reoperation
disease-free survival（DFS）
时间窗: After surgery-related treatment until the tumor recurrence，assessed up to 5 years
The period after Operation treatment \[tumor eliminated\] when no disease can be detected
overall survival（OS）
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
When the precise cause of Esophageal cancer death is not specified, this is called the overall survival rate or observed survival rate. Doctors use mean overall survival rates to estimate the patient's prognosis. This is often expressed over standard time periods, like one, five, and ten years.
次要结局
- Operation time(During the operation, an average of 2 hours)
- Proportion of patients who converted to thoracotomy and laparotomy(During the operation, an average of 2 hours)
- Number of lymph nodes removed during surgery(Pathology report time, an average of 4 days)
- intraoperative blood loss(During the operation, an average of 2 hours)
- Postoperative drainage(An average of 3 days after the operation)
- Intraoperative mortality rate(During the operation, an average of 2 hours)
- Postoperative pain score(An average of 3 days after the operation)
- Postoperative retention time of various types of drainage tubes(An average of 3 days after the operation)
- Postoperative hospital stay(Through postoperative hospital stay, an average of 4 days)
- Postoperative admission time to ICU(An average of 3 days after the operation)